Using Nicotine to Reverse Age-related Auditory Processing Deficits

University of California Irvine (UCI)

Status: Enrolling

Conditions: Aging; Auditory Perceptual Impairment

Treatments: Other: Placebo gum; Other: Nicotine gum

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04971954

1R01AG067073 (U.S. NIH Grant/Contract)

20139964

Details and patient eligibility

About

The present study will evaluate the effects of both aging and nicotine on psychophysical tasks and electrophysiological measures. Nicotine will be administered to study participants in the form of gum that is available as an over-the-counter medication. The hypothesis is that nicotine will reverse the detrimental effects of aging on auditory processing. The proposed experiments will characterize the effects of nicotine and may eventually lead to improved treatments of hearing loss in a variety of patient populations and in healthy aging.

Full description

Study participants will be recruited in two age groups: young (18-28 years) and old (60-85). Each participant will participate in two psychophysical and electrophysiological test sessions. For each of the two sessions, the participant will be administered gum before the test. For one of these sessions, the gum will be polacrilex that contains 6-mg nicotine, and for the other session, the gum will be a placebo control. The study will be double-blind, meaning that neither the experimenter nor the participant will know whether the participant has received nicotine or placebo for a given session. The study has a cross-over design, meaning that all participants will receive both nicotine and placebo in separate sessions. Finally, the order of drug administration will be counterbalanced, meaning that equal numbers of participants will receive 1) nicotine in session one and placebo in session two, and 2) placebo in session one and nicotine in session two.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• between 18 and 85 years of age
• non-smokers with a score of 0-2 out of 10 maximum on the Fagerström index of smoking dependency
• cognitive performance within two standard deviations of the CERAD mean

Exclusion criteria

• less than 18 or greater than 85 years of age
• deafness or excessive hearing loss
• smokers with a score between 3 and 10 on the Fagerström index of smoking dependency
• history of psychiatric illness, neurological disorders, diabetes mellitus, renal failure, or cardiovascular disease
• regular use of prescription medications (excluding oral contraceptives)
• drug dependency

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

Nicotine gum

Experimental group

Description:

Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication

Treatment:

Other: Nicotine gum

Placebo gum

Placebo Comparator group

Description:

The placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture.

Treatment:

Other: Placebo gum